Materials for reclaim, precious metal production by-products

Endpoint summary

Description of key information

No information on animal testing of "Materials for reclaim, precious metal production by-products" is available. However, "Materials for reclaim, precious metal production by-products" (Reclaim 1) does not meet classification criteria for STOT RE 1 or STOT RE 2.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: oral

Remarks:

other: prediction from hazard class

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: calculation tool MeClas (www.meclas.eu) is used

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

The C&L for toxic to specific target organ after repeated dose application of "Materials for reclaim, precious metal production by-products" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Critical effects observed:

not specified

"Materials for reclaim, precious metal production by-products" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, precious metal production by-products" may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of "Materials for reclaim, precious metal production by-products".

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Conclusions:

General note:
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification are as follows:
 
STOT RE 1; H372: C ≥ 0.5%
STOT RE 2; H373: 0.05% ≤ C < 0.5%

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. However, for lead compounds there are specific concentration limits given for STOT RE classification assigned by the lead industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification. Since, "Materials for reclaim, precious metal production by-products" (Reclaim 1, Reclaim 2 and Reclaim 4) does not contain any constituents in concentrations relevant for C&L, "Materials for reclaim, precious metal production by-products" (Reclaim 1, Reclaim 2 and Reclaim 4) must neither be classified as STOT-RE 1 nor STOT-RE 2 via the oral route, in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Materials for reclaim, precious metal production by-products", derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Remarks:

other: prediction from hazard class

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: calculation tool MeClas (www.meclas.eu) is used

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

The C&L for toxic to specific target organ after repeated dose application of "Materials for reclaim, precious metal production by-products" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Critical effects observed:

not specified

"Materials for reclaim, precious metal production by-products" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, precious metal production by-products" may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of "Materials for reclaim, precious metal production by-products".

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Conclusions:

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since "Materials for reclaim, precious metal production by-products" (Reclaim 1) does not contain any constituent which meets the described criteria for classification in respective amounts, "Materials for reclaim, precious metal production by-products" (Reclaim 1) has neither to be classified as STOT-RE 1 nor STOT-RE 2 via the inhalation route in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Materials for reclaim, precious metal production by-products", derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Remarks:

other: prediction from hazard class

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: calculation tool MeClas (www.meclas.eu) is used

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

The C&L for toxic to specific target organ after repeated dose application of "Materials for reclaim, precious metal production by-products" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Critical effects observed:

not specified

"Materials for reclaim, precious metal production by-products" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, precious metal production by-products" may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of "Materials for reclaim, precious metal production by-products".

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Conclusions:

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since "Materials for reclaim, precious metal production by-products" (Reclaim 1) does not contain any constituent which meets the described criteria for classification in respective amounts, "Materials for reclaim, precious metal production by-products" (Reclaim 1) has neither to be classified as STOT-RE 1 nor STOT-RE 2 via the inhalation route in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Materials for reclaim, precious metal production by-products", derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Substance specific information for the UVCB substance "Materials for reclaim, precious metal production by-products" is not available for the endpoint "Repeated Dose Toxicity". In order to meet the requirements for Annex VII till Annex X of Regulation (EC) 1907/2006, read across information from any constituents being relevant needs to be included. Due to the high number of constituents and variability in C&L it was agreed within the consortium to use the classification information from the individual constituents and calculate the resulting classification by using the "generic concentration limits of ingredients of the mixture classified as a specific target organ toxicant that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.9.3.4. “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool.

In total four different grades of "Materials for reclaim, precious metal production by-products" (Reclaim 1 - Reclaim 4) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Materials for reclaim, precious metal production by-products" three C&L entries (no classification (Reclaim 1),STOT RE 2, inhalation route (Reclaim 2 and 4)) and STOT-RE 1 oral route and STOT-RE 2 inhalation route (Reclaim 4)) for repeated dose toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

Classification of UVCB substances as being toxic to specific target organs after repeated dosing is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since, "Materials for reclaim, precious metal production by-products" (Reclaim 1) does not contain any constituents in concentrations relevant for C&L, "Materials for reclaim, precious metal production by-products" (Reclaim 1) does neither meet classification criteria as STOT-RE 1 nor STOT-RE 2, in accordance with Regulation (EC) 1272/2008.